Product code NJM

Device name

Bracket, Ceramic, Orthodontic

Medical specialty

Dental

Device class

2

Regulation number

872.5470

Review panel

DE

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

Y

Summary malfunction reporting

Eligible

Definition

An orthodontic ceramic bracket is a device composed of ceramic, which is intended to be bonded to a tooth, upon which an orthodontic wire is used to move the tooth to a new position.

Source

FDA openFDA device classification dataset